Application 050730

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZITHROMAX	AZITHROMYCIN	TABLET;ORAL	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050730-001	ZITHROMAX	AZITHROMYCIN	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050730-001	ZITHROMAX	EQ 600MG BASE	TABLET / ORAL		RLD	1996-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050730-001	ZITHROMAX	EQ 600MG BASE	TABLET / ORAL		RLD	1996-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050730-001	ZITHROMAX	EQ 600MG BASE	TABLET / ORAL		RLD	1996-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050730-001	ZITHROMAX	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	1996-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050730-001	ZITHROMAX	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N050730-001	AB	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Proficient Rx LP	44134421-cb0b-4e85-a3c8-d58bdb476fad	2024-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	2b821631-0df2-0fb2-e054-00144ff8d46c	2024-02-29	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	b77b347d-d357-4bdf-b985-49d9a1dd634c	2023-12-30	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bionpharma Inc.	a2754618-3df1-4b89-aa09-fdff4b71b7e4	2023-12-24	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	5ed68b5a-4093-49f1-871b-7b0da5f7be2d	2023-10-31	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	2023-09-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	af720986-48a9-48b5-bdd7-370f6a2f92e1	2023-04-24	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Teva Pharmaceuticals USA, Inc.	f6a52c0b-45db-422e-8c22-e867a11b4439	2023-03-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	22a2bdcb-3012-42fb-ac66-d1d879100940	2023-02-06	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	Alembic Pharmaceuticals Limited	5dca5a11-3c02-4a51-a35d-f91f37b8e00c	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Alembic Pharmaceuticals Limited	d5c95c30-564f-4b67-ac6d-9179cdfaa5a8	2023-01-13	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Alembic Pharmaceuticals Limited	deea1a56-84ed-4ce4-9d11-03271510c0a1	2023-01-12	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	Proficient Rx LP	e1172805-0930-4fb9-8a2f-e0d6a0430630	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	34e6364a-ac3d-434e-a90c-cb13ebcf7983	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	33140df5-420d-469f-b6c8-121e952a5cb6	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	Proficient Rx LP	b3761d39-9b79-4908-8b05-a1c91e599998	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	99ca0089-14a9-446d-8807-253ad5be3efa	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	cb40f4cf-15ae-47ab-8e0a-979467fa0d9e	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	25f2d819-ae38-4061-a897-bbcfce3739bf	2022-03-01	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-3080	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3080	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3080	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3080	ZITHROMAX	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div P	NDA	Current
59762-3080	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3080	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3080	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current
59762-3080	azithromycin	AZITHROMYCIN	Greenstone LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69393	SUPPL	2021-11-23
69374	SUPPL	2021-11-22
58433	SUPPL	2019-04-26
58414	SUPPL	2019-04-25
47837	SUPPL	2017-04-03
47784	SUPPL	2017-03-30
47184	SUPPL	2017-02-13
47183	SUPPL	2017-02-10
30400	SUPPL	2016-05-25
18139	SUPPL	2016-05-25
8137	SUPPL	2014-06-11
39208	SUPPL	2014-06-10
23725	ORIG	2013-03-12
39210	SUPPL	2013-02-21
8139	SUPPL	2013-02-21
39207	SUPPL	2012-11-06
30399	SUPPL	2012-11-06
39209	SUPPL	2012-06-11
8138	SUPPL	2012-06-08
18138	SUPPL	2011-02-04
30398	SUPPL	2011-02-03
39206	SUPPL	2010-08-19
8136	SUPPL	2010-08-17
39205	SUPPL	2009-04-23
8135	SUPPL	2009-03-10
8134	SUPPL	2007-11-08
39204	SUPPL	2007-11-07
39203	SUPPL	2004-04-05
30396	SUPPL	2004-03-28
30397	SUPPL	2004-01-22
30395	SUPPL	2002-10-16
8133	SUPPL	2002-07-22
39202	SUPPL	2000-11-13
30394	SUPPL	2000-11-13
22210	SUPPL	2000-11-13